Dry Eye SyndromesEarly Phase 1NCT05184517
A Feasibility Study to Evaluate the Tolerability of Oph1 Compared to Restasis in Healthy Volunteers
A Early Phase 1 study testing Oph1 and Restasis in people with Dry Eye Syndromes, run by OphRx Ltd. at 1 site in Israel.
Trial summary
20 healthy participants will be evaluated for tolerability and safety of a new eye drop formulation for treatment of Dry Eye Syndromes, Oph1 0.5% Cyclosporine A (CsA) compared with Restasis 0.05% CsA ophthalmic formulation. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Oph1 and Restasis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Jan 2023to 5 Sep 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 20-50 years, inclusive.
- Systemically and ophthalmologically healthy subjects evaluated during the clinical history.
- Best-corrected visual acuity (BCVA) 20/40 or better in both eyes.
- Negative Fluorescein staining in Fluorescein Corneal staining (FCS) in both eyes.
- Up to 0.5 Conjunctival redness in Conjunctival redness without slit lamp, in standardized lighting conditions, in both eyes.
- IOP (< 22mmHg), in both eyes.
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- No pathology findings in Slit-lamp biomicroscopy in both eyes.
- Ability to comply with the requirements of the study and complete the questionnaire and a full sequence of protocol-related evaluations.
- Ability to understand and provide written informed consent.
- In the judgement of the investigator, the participant can safely perform study activity.
Who cannot join
- Have chronic systemic disease of any form known.
- In the case of women: be pregnant, breastfeeding or planning to become pregnant within the study period or women without a history of hysterectomy, oophorectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
- Be a user of topical ophthalmic products of any kind.
- Being a chronic drug user.
- Be a user of contact lenses.
- Have a history of any type of eye surgery.
- Participating in clinical research studies 90 days prior to inclusion in the present study.
- In the judgement of the investigator, any condition that could interfere with the intent of the study or would make participation not in the best interest of the participant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility, Double Blind, Randomized, Crossover Study to Evaluate the Tolerability of Oph1 0.5% Cyclosporine Ophthalmic Formulation Compared to Restasis in Healthy Volunteers
20 healthy participants will be evaluated for tolerability and safety of a new eye drop formulation for treatment of Dry Eye Syndromes, Oph1 0.5% Cyclosporine A (CsA) compared with Restasis 0.05% CsA ophthalmic formulation.
Read the detailed description
20 healthy participants will be enrolled to the study and randomized into two groups of 10 participants each. In one group participants will be treated with Oph1 0.5% CsA ophthalmic formulation and in the other group with Restasis 0.05% CsA ophthalmic formulation. Both groups will be treated with the eye drops in the right eye only, twice a day (6-9 hours apart), for four days and once on the fifth day (total of 9 eye drops treatment for each), both groups will have 2 days of washout, and will be crossed to identical course of treatment with the other ophthalmic formulation. All eye drops treatments will be done on the medical site by one of the study staff unblinded to the treatment. The Investigator assessing the ocular signs and the participants will be blinded to study treatment.
- Conditions
- Dry Eye Syndromes
- Being tested
- Oph1, Restasis
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oph1Drug
0.5% CsA ophthalmic formulation, twice daily for 4 days and once on the fifth day, one eye (right).
RestasisDrug
0.05% CsA ophthalmic formulation twice daily for 4 days and once on the fifth day, one eye (right).
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Oph1 0.5% CsA ophthalmic formulation followed by Restasis 0.05% CsA ophthalmic formulation Receives: Drug: Oph1; Drug: Restasis |
| Arm II | Experimental | Restasis 0.05% CsA ophthalmic formulation followed by Oph1 0.5% CsA ophthalmic formulation Receives: Drug: Oph1; Drug: Restasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drop Discomfort VAS score
Eye Discomfort VAS scale from 0-100
Measured: up to Fifth day per treatment (last dose for each treatment)
Secondary outcomes (3)
Drop Comfort VAS score
Eye Discomfort VAS scale from 0-100
Measured: 1-minute post-Dose. Fifth day per treatment (last dose for each treatment)
Drop Discomfort Detailed VAS score. Calculated mean of all scores per treatment for each of the VAS scale.
Eye Discomfort, Itching, Burning, Foreign body feel VAS scales from 0-100
Measured: 1 minutes post-Dose instillation, Day 1-5, Day 8-12, AM
Drop Discomfort Detailed VAS score. Calculated mean of all scores per treatment for each of the VAS scale.
Eye Discomfort, Itching, Burning, Foreign body feel VAS scales from 0-100
Measured: 5 minutes post-Dose instillation, Day 1-5, Day 8-12, AM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start23 Jan 2023
- Primary completion6 Jul 2023
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- OphRx Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184517
- Sponsor's protocol ID
- CD-001
- Status last verified
- Dec 2021
- First submitted
- 21 Dec 2021
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility, Double Blind, Randomized, Crossover Study to Evaluate the Tolerability of Oph1 0.5% Cyclosporine Ophthalmic Formulation Compared to Restasis in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05184517
- Acronym / sponsor ID
- CD-001
- Conditions
- Dry Eye Syndromes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- OphRx Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
20 healthy participants will be evaluated for tolerability and safety of a new eye drop formulation for treatment of Dry Eye Syndromes, Oph1 0.5% Cyclosporine A (CsA) compared with Restasis 0.05% CsA ophthalmic formulation.
Detailed description
20 healthy participants will be enrolled to the study and randomized into two groups of 10 participants each. In one group participants will be treated with Oph1 0.5% CsA ophthalmic formulation and in the other group with Restasis 0.05% CsA ophthalmic formulation. Both groups will be treated with the eye drops in the right eye only, twice a day (6-9 hours apart), for four days and once on the fifth day (total of 9 eye drops treatment for each), both groups will have 2 days of washout, and will be crossed to identical course of treatment with the other ophthalmic formulation. All eye drops treatments will be done on the medical site by one of the study staff unblinded to the treatment. The Investigator assessing the ocular signs and the participants will be blinded to study treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: Oph1, Drug: RestasisOph1 0.5% CsA ophthalmic formulation followed by Restasis 0.05% CsA ophthalmic formulation |
| Arm II | Experimental | Drug: Oph1, Drug: RestasisRestasis 0.05% CsA ophthalmic formulation followed by Oph1 0.5% CsA ophthalmic formulation |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female aged 20-50 years, inclusive.
- Systemically and ophthalmologically healthy subjects evaluated during the clinical history.
- Best-corrected visual acuity (BCVA) 20/40 or better in both eyes.
- Negative Fluorescein staining in Fluorescein Corneal staining (FCS) in both eyes.
- Up to 0.5 Conjunctival redness in Conjunctival redness without slit lamp, in standardized lighting conditions, in both eyes.
Key exclusion criteria (8 listed)
- Have chronic systemic disease of any form known.
- In the case of women: be pregnant, breastfeeding or planning to become pregnant within the study period or women without a history of hysterectomy, oophorectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
- Be a user of topical ophthalmic products of any kind.
- Being a chronic drug user.
- Be a user of contact lenses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oph10.5% CsA ophthalmic formulation, twice daily for 4 days and once on the fifth day, one eye (right). | Drug | Arm I, Arm II |
| Restasis0.05% CsA ophthalmic formulation twice daily for 4 days and once on the fifth day, one eye (right). | Drug | Arm I, Arm II |
Primary outcome
Drop Discomfort VAS score
Time frame: up to Fifth day per treatment (last dose for each treatment)
Eye Discomfort VAS scale from 0-100
3 secondary outcomes
Drop Comfort VAS score
Time frame: 1-minute post-Dose. Fifth day per treatment (last dose for each treatment)
Drop Discomfort Detailed VAS score. Calculated mean of all scores per treatment for each of the VAS scale.
Time frame: 1 minutes post-Dose instillation, Day 1-5, Day 8-12, AM
Drop Discomfort Detailed VAS score. Calculated mean of all scores per treatment for each of the VAS scale.
Time frame: 5 minutes post-Dose instillation, Day 1-5, Day 8-12, AM
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oph1 and Restasis in people with Dry Eye Syndromes, run by OphRx Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drop Discomfort VAS score (time frame: up to Fifth day per treatment (last dose for each treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.